Summary
To assess the safety and tolerability at increasing dose levels of PF-06863135 in patients with relapse/ refractory multiple myeloma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
Official Title
MAGNETISMM-1 A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY, PHARMACOKINETIC, PHARMACODYNAMIC AND CLINICAL ACTIVITY OF ELRANATAMAB (PF-06863135), A B-CELL MATURATION ANTIGEN (BCMA) - CD3 BISPECIFIC ANTIBODY, AS A SINGLE AGENT AND IN COMBINATION WITH IMMUNOMODULATORY AGENTS IN PATIENTS WITH RELAPSED/REFRACTORY ADVANCED MULTIPLE MYELOMA (MM)
Details
Study C1071001 is a Phase 1, open label, multi dose, multi center, dose escalation, safety, pharmacokinetic (PK) and pharmacodynamic study of PF-06863135 in adult patients with advanced multiple myeloma who have relapsed from or are refractory to standard therapy. This is a two part study; Part 1 will assess the safety and tolerability of increasing dose levels of PF-06863135 and Part 2 will evaluate safety and anti-myeloma activity of PF-06863135 at the RP2Ds determined in Part 1.
Keywords
Multiple Myeloma, relapse/ refractory multiple myeloma, bispecific antibody, bispecific, BCMA, BCMA- CD3 bispecific, Phase 1, PF-06863135, dexamethasone, lenalidomide, pomalidomide, Plasma Cell Neoplasms, Thalidomide, Dexamethasone acetate, Antibodies, Immunoglobulins, Bispecific Antibodies, BB 1101, PF-06863135 monotherapy IV or SC, PF-06863135 + dexamethasone, PF-06863135 + lenalidomide, PF-06863135 + pomalidomide